The Movement is not just about information, it is about action! By addressing new challenges and forming Actionable Patient Safety Solutions (APSS) the PSMF believes we can reduce the number of preventable deaths in hospitals to ZERO by 2020.
Below you will find links to solutions to overcome some of the leading patient safety challenges facing hospitals today.

Executive Summary Checklist

Errors in the use of blood products are a significant cause of hospital patient morbidity and mortality. To eliminate these errors, we must implement an effective Patient Blood Management program, including the following actionable steps \cite{Meybohm_2017}:

A Commitment from hospital leadership to support a Patient Blood Management program that closes the performance gap by reducing unnecessary transfusions while speeding up needed blood transfusion and care for patients who truly need it.

Clinical and safety leadership endorse the plan and drive implementation across all providers and systems.

Establish the Patient Blood Management Committee, which replaces the traditional hospital transfusion committee, and appoint an MD chairperson to be responsible and accountable for leading this group.

On a monthly basis, distribute the blood product usage report by clinicians across the hospital to hospital leaders.

Continuously monitor the effectiveness of the Patient Blood Management program, and use the results of this monitoring in medical staff educational sessions as a part of Continuous Quality Improvement (CQI).

The Performance Gap

Anemia

The healthy human body contains approximately 5-liters of blood and about 40 to 45% of blood consists of red blood cells (RBCs). Impaired blood formation, blood loss or destruction leads to anemia which represents the most common blood disorder worldwide.

About 30% of the world’s population is anemic, in other words, 1 out of every 3 people are anemic \cite{24297872}. The underlying causes can be of various etiologies; however, 30% can be attributed to malnutrition. For example, iron-deficiency is the most prominent cause due to a chronic blood loss and low iron consumption.1 Although considered a silent disease, anemia has a list of typical symptoms such as weakness, fatigue and difficulty in concentration to name a few, resulting in reduced quality of life and productivity. Due to the natural occurrence of these symptoms in our daily life the presence of anemia is often overlooked, underdiagnosed, ignored and undertreated especially in women of childbearing years (approximately ½ a billion women) \cite{23210492}. This frequently underestimated health problem is present in both the industrialized world as well as in developing countries and represents 68.3 million years lived with disability (YLD) and consumes 8.8% of all ailments worldwide \cite{18498676}.

In clinical practice hemoglobin (Hb) levels are used to determine anemia. The World Health Organization (WHO) defines a normal Hb level of ≥13 g/dL for men and ≥12 g/dL for menstruating women. Recent studies reveal the severe impact of anemia on surgical outcomes implicating anemia as a serious health condition and an independent risk factor for patients. Musallam et al., conducted a retrospective trial comprising 227,425 patients undergoing any kind of non-cardiac surgery. Non-anemic patients showed a 30-day mortality rate of 0.78% (over 158,000 patients)\cite{21982521}. In contrast, the presence of any anemia whether mild (Hb level of 10-13 g/dL in men and 10-12 g/dL in women) amplified patient’s mortality by a factor of 4.5 (3.52% in over 57,000 patients). Moreover, when patients were severely anemic (Hb level below 10 g/dL) 30-day mortality rate increased by factor 13 (more than 11,000 patients). Baron and coworkers analyzed medical reports of more than 39,000 patients confirming the association between the presence of mild anemia (Hb level of 10-13g/dL in men and 10-12g/dL in women) and increased mortality (+20% in multivariate models), longer duration of hospitalization and more frequent admission to intensive care \cite{baron2014european}. Longer hospital stays are associated with increased cost and patients are at an increased risk for other healthcare-associated conditions like falls and healthcare-associated infections (HAIs).

Being a worldwide epidemic with significant consequences addressed above, anemia requires prompt evaluation and treatment.1 Approximately 234 million surgeries are performed worldwide and about 70.2 million patients are anemic prior to surgery displaying additional (avoidable) risk factors \cite{18582931}. Of this patient population, over 21 million patients possess iron-deficiency and iron deficiency anemia that can be reverted by iron replacement \cite{Shander_2014,Whitlock_2015}. In addition, postoperative iron-deficiency anemia has an even higher prevalence, affecting up to 32 million patients.

Another emerging concept is Hospital-acquired (Associated) Anemia (HAA). Data from 10 Cleveland Clinic Hospitals revealed that 3 out of four patients admitted to their hospitals were anemic. Since this was a multi-hospital study, it is easily generalizable suggesting the high prevalence of this condition in hospitalized patients.\cite{Koch_2013} Discharge data suggest little to no appropriate therapy for this condition except for red cell (RBC) transfusion.

Moreover, a presence of anemia on admission will be made worse with ongoing blood loss dome from surgery but most from phlebotomy for redundant and unneeded tests. More than 25 million liters of phlebotomy blood a year are discarded in sewers which are 4 times the amount we transfuse \cite{Levi_2014}.

One of the if not the highest risk of anemia in hospitalized patients is the current default treatment, transfusion of RBCs. Transfusions have been demonstrated to be an independent risk factor for both morbidity and mortality and as a treatment of anemia compound the risks \cite{Isbister_2011}. Whitlock et al. analyzed in a retrospective study with 1,583,819 patients (41,421 transfused) the association of RBC transfusion and stroke and myocardial infarction. Transfusion of a single unit of RBC already increased the risk of perioperative ischemic stroke or myocardial infarction by 2.3 fold (Whitlock 2015).

Transfusions

RBC transfusions are administered to patients during active bleeding, chronic blood loss or poor production in order to increase the body’s oxygen carrying capacity. Despite the perceived benefit, many RBC transfusions have been deemed unnecessary resulting in risk or harm and defined as “overuse”. Overuse in healthcare has been defined by the Institute of Medicine (IOM) as use “in circumstances where the likelihood of benefit is negligible or zero, and therefore the patient is exposed to the risk of harm”. In general, health care providers, as well as health policy makers, are largely unaware of the significant impact that overuse in this area has on quality and safety of patients, or the cost and resource savings that can be realized by actively addressing RBC overuse.

RBC transfusion is one of the most frequent procedures performed in U.S. hospitals and Europe, with one in ten in-patients receiving one or more blood units \cite{healthcare2009hcup}. RBC transfusion practices are highly variable by institution, procedure, and physician \cite{22531332}. Meta-analysis of risk-adjusted observational studies has shown that RBC transfusions are associated with a 69% increase in mortality and 88% increase in morbidity \cite{18496365}. Restrictive transfusion practices, in which RBC transfusions are given at lower-than-usual hemoglobin threshold, have been proven safe in multiple randomized controlled trials \cite{22513904}. These studies done repeatedly, ignore the etiology and other available modalities to effectively treat or even cure anemia. (Friedman 2012)

In response to this unmet medical need, the concept of Patient Blood Management evolved to effectively address anemia, coagulation abnormalities and assert blood conservation for all and has now shown to reduce or eliminate transfusions when applied as a multimodality approach with reduced resource utilization and improved patient outcome \cite{Goodnough_2012,world2010availability}.

The costs of RBC transfusion are not widely appreciated. In the past, the cost was estimated and ignored as part of “doing business”. In 2010, Activity Based Costing (ABC) employed in one study revealed the cost of transfusion to be between $522 and $1,183 per unit (depending on geographic location) – the study did not account for any morbid or mortality costs \cite{Shander_2010}. New infectious agents, such as the Zika virus, have also added to the ongoing risk of allogeneic transfusions, ultimately contributing to the to significant cost of this therapy \cite{Goodnough_2017}. Beyond the cost of transfusion, each RBC unit transfused is associated with increased cost of care. For example, transfusions that occur at higher hemoglobin levels increase the cost of care more than those given at lower hemoglobin levels \cite{Murphy_2007}. As mentioned above, many transfusions are unnecessary and therefore should be avoided. A systematic, expert review of 494 studies for positive impact on health outcome showed that 59% of RBC transfusions are "inappropriate" resulting in harm to patients (Ibister 2011). Given the risk and cost of RBC transfusions, there is a growing recognition of the need to implement strategies to reduce transfusions. The Joint Commission has introduced Patient Blood Management Performance Measures that help evaluate the appropriateness of transfusions as a continuous quality indicator but lack any recommendation for anemia management \cite{joint2011implementation}. The American Medical Association and the Joint Commission, with Centers for Medicare and Medicaid Services participation, recently identified RBC transfusions as one of the top five overused procedures in medicine \cite{22667055}.

Hospitals and physicians have continued to face challenges in adopting evidence-based practice guidelines for RBC transfusions. In spite of the strong need to reduce RBC transfusions, existing tools for transfusion decision making may be lacking and this paucity may contribute to inappropriate transfusions. For example, estimated blood loss during surgery is often greater than actual blood loss, leading to incorrect assessments about the need for RBC transfusion and resulting in ‘over-transfusions’\cite{hill2011accuracy}. In addition, laboratory hemoglobin values, which are used as a primary indicator for RBC transfusions, are only available intermittently and are often delayed – leading to transfusion decisions without a laboratory hemoglobin value.(Frank 2012) In addition, repeated phlebotomies for laboratory tests are associated with induction and/or aggravation of anemia resulting in RBC transfusions in hospitalized patients \cite{24138554,21824940}. Technology to augment laboratory hemoglobin measurements, such as noninvasive and continuous hemoglobin monitoring, may provide clinicians with additional real-time trending information to determine if hemoglobin values are rising, falling, or remain stable, which may permit clinicians to make more informed and early RBC transfusion decisions.

It is estimated that the use of process changes and technology to reduce RBC transfusions can save the U.S. healthcare system in excess of five billion dollars per year, while significantly improving quality and safety \cite{at27}. Closing the performance gap will require hospitals and healthcare systems to commit to actions that will result in better healthcare outcomes with efficient use of healthcare resources. In the so far largest multicentre trial (almost 130,000 patients) in the world, it has been shown that the implementation of PBM reduces significantly the amount of transfused blood, costs and kidney damage. Overall, the implementation of PBM is safe and effective \cite{27163948}.

Leadership Plan

Based on sustained success of Patient Blood Management programs in USA, Australia, Europe, and Asia, proposals to implement change are listed below:\cite{27317382,27001367,20667328,23927725,24931841,24393629,24410741}

Executive Summary Checklist

Medication errors (wrong drug, wrong dose, wrong patient or route of administration and wrong documentation) are a major cause of inpatient morbidity and mortality. An effective program to reduce medication errors will require an implementation plan to complete the following actionable steps:

Hospital leadership must understand the medication safety gaps in their own system, and be committed to a comprehensive approach to close those gaps.

Create a multidisciplinary team, including physicians, nurses, pharmacists, and information technology personnel to lead the project.

Implement systematic protocols for medication administration, featuring checklists for writing and filling prescriptions, drug administration, and during patient transitions of care, as well as other quality assurance tools. These tools will include:

Installing the latest safety technology to prevent medication errors, such as the BD Intelliport™Medication Management System and First Databank FDB MedKnowledge™ system or other drug dosing solutions for individual or categories of medications such as Monarch Medical Technologies solution for calculating IV & SubQ insulin doses.

Use barcoding for drug identification in the medication administration process.

Clinical Decision Support Systems (CDSS) should be implemented if the institution or system has the infrastructure in place to add CDSS for specific medications or groups of medications, as an extra layer of safety \cite{28816851}.

Practice the Six Patient Rights on Medications: right patient, right drug, right dose, right route, right time of administration and right documentation of medication administration. All care providers should use this simple checklist.

Provide education of all hospital personnel in the principles above. Monitor the effectiveness of this education at regular intervals.

Review monitoring/reporting results at medical staff meetings and educational sessions as a part of Continuous Quality Improvement (CQI).

Regulatory Vendor Background checks. There are over 100 different classifications for FDA manufacturing with each registration allowed a different type of labeling, packaging, verification and delivery. If the drug is not delivered correctly in the first place to the hospital or physician practice, then the concept of Right Drug cannot be confirmed.

Executive Summary ChecklistIn order to establish a program to improve hand hygiene and reduce healthcare-associated infections (HAIs), the following implementation plan will require actionable steps. The following checklist was adapted from the WHO Hand Hygiene Self-Assessment Framework \cite{2010a} and based on research studies in which sustainable improvement was achieved \cite{Bouk_2016} \cite{Kelly_2016}\cite{Son_2011}\cite{Robinson_2014}.Gain commitment from senior leadership to make hand hygiene compliance an organizational priority by setting clear requirements and an adequate budget for:Staff PerformancePerformance Measurement and Feedback that is timely and actionableAccountability for Performance Improvement at facility and unit leadership levels as part of an overall Organizational Hand Hygiene Guideline. Cascade this message to the entire organization on an on-going basis. Ensure that alcohol-based hand rubs and soap are available as close to the point of care as is reasonable.Establish a hand hygiene team responsible for implementation of the Hand Hygiene Protocol.The protocol should include mandatory training for all healthcare workers (HCWs) upon hire and on-going at least once annually. Training to include:Proper technique for hand rubbing and soap and water washingIndications for hand rubbing vs soap and water washing (WHO or CDC Guideline)How to speak up when fellow HCWs do not comply (psychological safety is a vital condition of an effective safety culture)Education for patients, family members and visitors. Performance Evaluation and FeedbackIt is essential to measure hand hygiene compliance accurately and reliably using a validated method capable of capturing and reporting on 100% of all hand hygiene events such as an evidence-based electronic hand hygiene compliance system. Such systems have been shown to lead to sustainable improvement, reduced infections & costs and a positive impact on patient safety culture \cite{Bouk_2016} \cite{Kelly_2016}\cite{Michael_2017}\cite{Son_2011}.Measure hand hygiene compliance using an evidence-based, validated electronic hand hygiene compliance system. Provide performance feedback to unit leadership and frontline staff on a daily or weekly basis using evidence-based behavior change feedback models \cite{21775022}. Follow technology suppliers’ evidence-based recommendations for how to best implement technology and provide timely feedback to healthcare workers.Reminders in the workplace such as posters, brochures, leaflets, badges, stickers, etc. can be used provided they are consistent with the overall Hand Hygiene Protocol and any organizational wide campaigns to focus attention on the importance of hand hygiene.

Executive Summary Checklist

Congenital Heart Disease (CHD) is one of the most common types of birth defects. Critical Congenital Heart Disease (CCHD), including ductal-dependent lesions, represents 40% of death caused by CHD. CCHD is life-threatening and is typically identified in the first year of life. Early intervention in CCHD is imperative and remains an important clinical challenge. Historically, due to the lack of physical signs and difficulties in screening mild cyanosis in newborns, a third of babies were discharged unchecked. A fetal ultrasound can identify increased structural abnormalities and proportions; however, this detailed ultrasound is operator-dependent and potentially inconsistent. Pulse oximetry screening is a universally accepted test that increases overall detection of CCHD to over 90% and identifies babies with non-cardiac, hypoxemic conditions such as congenital pneumonia, early-onset sepsis, and pulmonary hypertension as well.

To address the failure to detect CCHD in newborns, we should implement the following actionable steps:

Make an organization-wide [MG nationwide] commitment to implement a universal pulse oximetry screening program for newborns.

Select technology proven to be effective for newborn screening. The technology must monitor and accurately read through during motion and low perfusion. Masimo Signal Extraction Technology (SET) pulse oximetry (until another technology is proven to be equivalent) [MG I would present this just as SET. This is a Masimo trademark.]

Determine the screening protocol

Age at screening: >24 hours or prior to discharge

Obtain pulse oximetry measurements from preductal (right hand) and postductal (either foot) sites [MG In CCHD, the right hand may be post ductal. Both hands is potentially better than right hand and foot. May just want to say pre and post ductal]

Screening results which will be considered positive and require further investigation

SpO2 <90% from any site; or

SpO2 <95% from the right hand or either foot

If initial SpO2 measurement is <95%, proceed with up to two additional SpO2 measurements.

If the second and third SpO2 measurements read >95% the screening is negative.

If the second and third SpO2 measurements are <95% the screening is positive.

>3% difference in SpO2 measurements between the right hand and either foot (repeat three times as described in the bullet above)

Additionally, if the Perfusion Index (PI) <0.7 that should increase the need for assessment of the baby (if <0.4 the baby should be immediately assessed)

Develop a process for continuous improvement by educating and communicating with staff and implementing measures to improve processes in order to meet the universal newborn screening objective.

The Performance Gap

Congenital heart disease (CHD) is the most common birth defect, affecting approximately 8 in 1,000 live-born infants \cite{Reller_2008,Bernier_2010}. Nearly 40,000 infants are born with CHD per year in the US, and 1.35 million globally \cite{Hoffman_2002,22078432}. Critical congenital heart disease (CCHD), including ductal dependent lesions, affects between one-quarter and one-third of these infants \cite{Oster_2013,26086632,25963011}. CCHD represents about 40% of the deaths from congenital anomalies and the majority of the deaths due to CHD that occur in the first year of life.(Hoffman 2002) In 2012, before newborn screening programs were introduced in the United States, it was estimated that between 70-100 infants died each year from late-diagnosed CCHD \cite{Govindaswami_2012}. It is now believed that the number of deaths is closer to 120 per year \cite{28837548}. [MG these two sentences don't work well together; after screening, are we seeing increased or decreased death?]

Antenatal ultrasound and physician examination after birth improve detection and perinatal outcomes for certain forms of CCHD \cite{Tworetzky_2001,Bonnet_1999}. Evidence showed that prenatal detection increased every year (2006-2012); prenatal detection now occurs in 34% of patients \cite{Quartermain_2015}. The benefit of a CCHD diagnosis before birth allows for counseling and coordination of delivery at an experienced cardiac center.

The gap in patient safety is that more than 30 percent of CCHD deaths have been attributed to late or missed diagnosis \cite{Chang_2008}. It is estimated that 2,000 infants/year die or are undiagnosed in the US and some 300,000 infants/year die globally \cite{Salvi_2016}. The burden of undiagnosed cases in the developing world is significant, with fewer than half of CHD cases diagnosed in the first week of life \cite{Hoffman_2013}. The magnitude of the problem has been extensively documented \cite{Singh_2014,de_Wahl_Granelli_2014,Ewer_2014,Ewer_2014a,Ewer_2013,Ewer_2013a,GRANELLI_2007}.

Pulse oximetry noninvasively measures oxygen saturation (SpO2) and pulse rate. In 2009, de-Wahl Granelli et al published a breakthrough cohort study in which 39,821 infants were screened for CCHD by identifying abnormal SpO2 measurements from Signal Extraction Technology (SET) pulse oximetry. SET's ability to measure through motion and low-perfusion is essential for accurate CCHD screening \cite{de_Wahl_Granelli_2009}. In a separate CCHD screening study of 20,055 asymptomatic newborns, Ewer et al, confirmed the importance of utilizing SET technology that can “produce accurate saturations that are stable in active neonates and in low perfusion states, making them suitable for use in the first few hours of a newborn baby’s life" \cite{22284744}. In 2014, Zhao et al reported similarly positive results from a prospective study using SET in more than 100,000 newborns in China \cite{24768155}.

The addition of pulse oximetry screening to antenatal ultrasound and physical examination may increase detection rates for CCHD to over 90%. Furthermore, the detection of non-critical CHDs and significant non-cardiac neonatal conditions, such as respiratory problems or early-onset sepsis, is an additional benefit. However, clinicians need to be aware that, although combining pulse oximetry screening with other screening methods will reduce this diagnostic gap, some babies will still be missed. The Journal of Pediatrics has published a study estimating the number of infants with critical congenital heart defects (critical CHDs) potentially detected or missed through universal screening for critical CHDs using pulse oximetry \cite{23266220}. CDC researchers estimated that about 1,755 infants with critical CHDs would be diagnosed late (meaning on or after the third day after birth). Of these, about half (875 infants) with a critical CHD would be detected through newborn screening using pulse oximetry, but an equal number (880 infants) might still be missed each year in the United States.

Most studies report that the lesions most often missed are those causing obstruction to aortic outflow (e.g. coarctation and interrupted arch), which may not necessarily be detected in antenatal ultrasound, physical examination, or by abnormal SpO2 values from pulse oximetry. However, an additional SET pulse oximetry measurement may increase detection of CCHD with obstructions to aortic outflow. This measurement is called perfusion index (PI), which is an assessment of strength of perfusion at the monitored site. In a 2007 study, Granelli showed that adding abnormal PI to pulse oximetry screening may increase sensitivity to identifying CCHD with an obstruction to the aortic outflow. The authors of this study also noted that adding PI to the screening criteria may also result in an increase in false positives. [MG reference?]

In 2011, the federal CCHD workgroup, with members selected by the US Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, the American College of Cardiology Foundation, the Newborn Foundation, the March of Dimes, and the American Heart Association, developed a report: Strategies for Implementing Screening for Critical Congenital Heart Disease \cite{21987707}. After a thorough review, the workgroup relied upon a thorough body of evidence and independent published studies to recommend that “screening be performed with motion tolerant pulse oximeters that report functional oxygen saturation, have been validated in low-perfusion conditions, have been cleared by the FDA for use in newborns, and have a 2% root mean-square accuracy.”

Several domestic and international studies have shown parents are predominantly satisfied with pulse oximetry screening and those whose babies had a false positive result were no more anxious than those with true negative tests (Ewer 2012). Parents generally perceived it as an important and valuable test to detect ill babies. Additionally, all staff groups (healthcare assistants, midwives, nurses and doctors) were predominantly positive about the testing procedure and perceived the test as important.

Screening for CCHD not only reduces pain and suffering of infants and families but can also reduce costs associated with severe cardiovascular and other organ or neurological compromise upon delayed admission to a cardiac unit – and has been tied to significantly reduced mortality, fewer poor surgical outcomes, and lower incidence of prolonged ventilation and potential developmental issues \cite{23918890}.

Relative to the developing world, the prevalence of certain heart lesions varies significantly on the global map, as does the burden of hypoxemia-related conditions such as neonatal pneumonia, sepsis, necrotizing enterocolitis (NEC), and PPHN.(Hoffman 2013) Every year nearly 41% of all under-five child deaths are among newborn infants, babies in their first 28 days of life or the neonatal period \cite{world2012newborns}. Three-quarters of all newborn deaths occur in the first week of life, and 1/3 of these newborn deaths are from infection, such as pneumonia, tetanus, and sepsis.30 Each of these conditions are likely to manifest with below normal oxygen saturation. Some are preventable deaths in that when diagnosed in a timely fashion, a course of antibiotics and/or supplemental oxygen therapy can save a life or improve an outcome.

Considerations regarding algorithms for screening

A recent review describes the experience of CCHD screening in the United States in reference to optimizing the algorithm for screening, educating all stakeholders and performing screening using the proper equipment \cite{27244826}. There are many factors to consider when determining the optimal screening algorithm, including the balance of sensitivity and specificity, resource utilization, cost, high altitude and timing of screening. For this reason, other screening protocols have been evaluated in the United States and in other countries \cite{27940777,27603536}. For this reason, other screening protocols have been evaluated in the United States and in other countries. For example, infants at high altitude may have a lower oxygen saturation than those at sea level with potential implications at elevations over 6,800 feet. Therefore, to identify the optimal algorithm in particular settings, it may be necessary to modify the screening protocol described in this document, including the saturation cutoff points and the timing of screening.

A certain degree of controversy still remains, and debate continues regarding the most appropriate time to screen, the most effective screening pathway, what saturations are acceptable, which conditions are we trying to identify and screening outside the well-baby nursery.

When evaluating algorithms, it is important to consider sensitivity, specificity, and false-positive and false-negative rates. It is also vital that screening leads to timely diagnosis (ie, before presentation with acute collapse).

The screening should be pre-and post-ductal as analysis of raw saturation data from infants who had both limb measurements shows that some infants with CCHD would be missed by postductal testing alone.

False-positive rate is significantly higher with earlier testing (<24 hours). This led to recommendations that screening be performed after 24 hours of age.

However, analysis of recent studies show that many false-positive tests (30%–80%) have alternative non-cardiac conditions (eg, congenital pneumonia, early-onset sepsis, or pulmonary hypertension), which may be equally as life-threatening as CCHD if diagnosed late.

In published studies that adopted earlier screening (< 24 hours) the false-positive rate was higher, but more non-cardiac disease was identified.

In some countries, mothers and infants are discharged from the hospital within 24 hours after birth, and an increasing proportion is born at home. In these circumstances, screening in hospital > 24 hours is not practical.

Additionally, infants at high altitude may have a lower oxygen saturation than those at sea level with potential implications for screening for CCHD at elevations over 6,800 feet. Therefore, to identify the optimal algorithm in particular settings, it may be necessary to modify the screening protocol described in this document, including the saturation cutoff points and the timing of screening.

Although usually reserved for former premature infants going to high altitude, any infant who fails high altitude stress testing (HAST) also merits special consideration and may require an echocardiogram to confirm normal anatomy.

Be all this as it may, if SpO2 is < 90% in either limb the infant needs to be assessed immediately. If SpO2 is between 90-94% in one or both limbs and the infant does not look completely healthy, clinical assessment is mandatory without delays for repeated measurements. If an infant is completely healthy, the measurement should be repeated as described. Finally, there is no need to do an echocardiogram immediately, as many babies with positive screening do not have CCHD. [Mg this last sentence is confusing and should be removed, a failed algorithm occurs in a two hour period; we don't want babies sent home without an echo because there is no need to do an echo immediately]

In summary, the lack of a systematic approach to prevent failure to rescue in CCHD significantly affects patient safety, quality, and cost of care. Universal newborn screening with pulse oximetry technology has been shown to increase the detection of CCHD by identifying potential abnormalities that are not apparent in prenatal or postnatal examinations. Closing the performance gap with CCHD will require hospitals, healthcare systems and all members of the neonatal healthcare team (RN’s, RT’s and MD’s) to commit to action in the form of specific leadership, practice, and technology plans for all newborn infants.

Leadership Plan

Implement a plan that includes fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, and action.

Hospital governance and senior administrative and medical and nursing leadership commit to becoming aware of this major performance gap in their own healthcare system.

Hospital governance, senior administrative leadership, and clinical/safety leadership close their own performance gap by implementing a comprehensive approach to addressing the performance gap

Set a goal date to implement the plan to address the gap with measurable quality indicators.

Allocate a budget for the plan to be evaluated by governance boards and senior administrative leaders.

Clinical/safety leadership endorse the plan and drive implementation across all providers and systems.

Conduct data collection and analysis to be used for implementation and assessment of outcomes.

Determine the oxygen targeting guideline that healthcare providers should implement:

The SpO2 for a preterm baby breathing supplemental oxygen should not exceed 95%.

The SpO2 for other larger infants and neonatal patients breathing supplemental oxygen should stay in the range of 88-95 or 90-96% depending on infant and condition.

When SpO2 dips below the desired % or when the low alarm sounds, avoid a response that results in high saturation (>95%).

In order to accomplish this, the monitor alarms should always be on and active when an infant is breathing supplemental oxygen.

Neonates in an intensive care environment should always be monitored by a pulse oximeter capable of monitoring through motion and low perfusion with appropriate alarm limits.

The high SpO2 alarm should be set to 95%, depending on the infant.

The low SpO2 alarm should be set no lower than 85%.

Alarms signaling should receive attention from the nurse/doctor/respiratory therapist.

When a baby is not breathing supplemental oxygen or receiving any form of respiratory support, but is being monitored for desaturations, the low SpO2 alarm should be set at 85% and the high alarm can be turned off.

Implement your action plan for including educational activities, workshops, and tools for all members of the neonatal healthcare team.

Develop a process for continuous improvement by communicating with staff and implementing measures to improve processes in order to meet the oxygen targeting objective.

The Performance Gap

It has been clear for many decades that avoiding hypoxia in neonatal care is associated with increasedsurvival and lower rates of cerebral palsy, other significant neurologic compromise. For this reason, hypoxia should be avoided; this isnot to say that hyperoxia should be allowed. Supplemental oxygen in newborn infants has been over-utilized worldwide. This practice has been associated with prolonged hospitalizations, blindness for life dueto retinopathy of prematurity (ROP), cancer in childhood, chronic lung disease, developmental disabilities,periventricular leukomalacia, cerebral palsy and other oxidant-stress related adverse effects includingDNA damage, endocrine and renal damage, decreased myocardial contractility, alveolar collapse, infection,inflammation and fibrosis \cite{Collins_2001,12769184,17537007,15613575,18458550,18446174}. Most if not all of these complications are as a result of care in the newbornperiod and cannot be fully eradicated. However, evidence shows eliminating inappropriate oxygenadministration and increasing the use of oxygen monitoring can lead to significantly decreased rates ofthese preventable conditions \cite{24838096,Sola_2015}.

The use of unnecessary oxygen or suboptimal administration of oxygen, and the resulting prolonged hospital stays add significantly to health care costs, not to mention the tremendous emotional costs of preventable chronic conditions. Actively addressing the administration and monitoring of oxygen in newborn infants to prevent both hypoxia and hyperoxia can realize significant improvements in the quality and safety of healthcare as well as cost savings \cite{23268664}.

Hospital practices for oxygen monitoring are variable. Many delivery rooms and neonatal intensive care units worldwide adhere to outdated or otherwise inappropriate protocols. The evidence has shown that excessive oxygen administration during the first few minutes of life is noxious. Yet, in many delivery rooms worldwide, pure oxygen (100% O2) is still administered unnecessarily, FiO2 is not measured, and oxygen saturation (SpO2) levels are not adequately monitored \cite{21091987,Shah_2012,Bizzarro_2013,Chow_2003,Deulofeut_2006,2010}. Therefore, there is an opportunity to prevent many adverse effects through education on appropriate oxygen management, such as the measurement of oxygen titration with a blender and monitoring the infant’s saturation level with pulse oximetry technology that can measure through motion and low perfusion \cite{12563061}.

In a two-phased study of two centers that previously used conventional pulse oximetry, both centers simultaneously changed their neonatal oxygen targeting guideline, and one of the centers switched to Signal Extraction Technology pulse oximetry.14 In the first phase of the study, there was no decrease in retinopathy of prematurity at the center using non-Signal Extraction Technology; but there was a 58% reduction in significant retinopathy of prematurity and a 40% reduction in the need for laser eye treatment at the center using Signal Extraction Technology. In the second phase of the study, the center still using non-Signal Extraction Technology switched to Signal Extraction Technology and it experienced similar results as the center already using Signal Extraction Technology. In the follow up study, the outcomes of 304 very low birth weight infants whose oxygen targeting was performed with non-Signal Extraction Technology pulse oximetry were compared with 396 post-initiative infants whose oxygen targeting was performed after switching to Signal Extraction Technology pulse oximetry.13 After switching to Signal Extraction Technology, there was a 59% reduction in incidence of severe ROP and a 69% reduction in ROP requiring surgery.

A summary of recent publications on extremely premature infants randomly assigned to a lower target oxygen-saturation intention to treat (85 to 89%) or higher target SpO2 intention to treat (91 to 95%) has shown there was neither increased mortality nor serious brain injuries as a result of avoiding hyperoxia in preterm infants \cite{Stenson_2011,Saugstad_2011,Castillo_2008,Askie_2011}. Also a recent presentation by Askie et al (Cochrane review) shows that there is no difference in the primary outcome of death or disability between the two intentions to treat studied, a higher (91-95%) versus a lower (85-89%) arterial oxygen saturations. Higher rate of NEC occurred with lower intention to treat (85-89%) and a higher rate of severe ROP with higher target range (91-95%). Recently the Committee on Fetus and Newborn of the AAP have made clinical recommendations which are included in this document \cite{Cummings_2016}.

Therefore, an intention to treat with SpO2 of 85-89% should be avoided. There are several issues that suggest extreme caution should be used in the interpretation of these randomized controlled trials \cite{Manja_2015,25357098,24973289}. Additionally, narrow ranges are difficult to maintain for more than 50-60% of the time \cite{Di_Fiore_2014}. To date, the “perfect” SpO2 target range is still not known for all newborns at all times \cite{Saugstad_2010}.

In summary, in extremely low birth weight infants the ideal oxygen saturation range or intention to treat remains unknown and is a compromise among negative outcomes associated with either hyperoxemia (ROP, BPD) or hypoxemia (NEC, death). The appropriate SpO2 range for an individual infant will depend on the type of SpO2 monitor used, gestational age, postnatal age, hemoglobin A concentration, hemoglobin level, oxygen content, cardiac output, clinical diagnosis and illness severity \cite{Castillo_2010}. Despite this variability, it is clear that in order to improve clinical outcomes, some clinical practices must be eradicated and replaced with guidelines of clinical care aimed at avoiding both hyperoxia and hypoxia.

Alarms:

Alarms should always be operative (do not disconnect or deactivate alarms).

Alarm limits are used to avoid harmful extremes of hyperoxemia or hypoxemia.

Busy NICU nurses respond much better to SpO2 alarms rather than to “mental SpO2 target ranges or intention to treat”.

Given the limitations of SpO2 and the uncertainty regarding the ideal SpO2 intention to treat for infants of extremely low birth weight, wider alarm limits are easier to target.

The lower alarm limit generally needs to extend somewhat below the lower SpO2 chosen as the intention to treat. It must take into account practical and clinical considerations, as well as the steepness of the oxygen saturation curve at lower saturations. It is suggested that the low alarm for extremely low birth weight infants be set no lower than 85% ( 86-87% may also be appropriate).

The upper alarm limit should not be higher than 95% for extremely low birth weight infants while the infant remains on supplemental oxygen or any form of ventilatory support.

ROP and other morbidities can be exacerbated by hyperoxemia. For example, at 5 years of age, motor impairment, cognitive impairment and severe hearing loss are 3 to 4 times more common in children with than without severe ROP.

Based on these considerations, there is a need to introduce clinical measures at all institutions caring for newborn infants to close the gap between knowledge and practice. The lack of a systematic approach to prevent hypoxia and hyperoxia significantly affects patient safety, quality, and cost of care. Closing the performance gap will require hospitals, healthcare systems and all members of the neonatal health care team (RN’s, RT’s and MD’s) to commit to action in the form of specific leadership, practice, and technology plans to improve safety for newborn infants who require oxygen supplementation.

Leadership Plan

Implement a plan that includes fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action \cite{sonot1}.

Hospital governance and senior administrative leadership commit to become aware of this major performance gap in their own healthcare system.

Hospital governance, senior administrative leadership, and clinical/safety leadership close their own performance gap by implementing a comprehensive approach to addressing the performance gap.

Set a goal date to implement the plan to address the gap with measurable quality indicators - “Some is not a number. Soon is not a time" \cite{sonot2}.

Allocate a budget for the plan to be evaluated by governance boards and senior administrative leaders.

Clinical/safety leadership endorse the plan and drive implementation across all providers and systems.

Collect data and perform analysis to be used for implementation and assessment of outcomes.

Address and readdress two questions for quality improvement and to address gaps: Are we doing the right things? Are we doing things right?

Executive Summary ChecklistSevere hypoglycemia (SH) causes significant morbidity and occasional mortality in hospitalized patients. The establishment of an effective program to reduce errors in the recognition and treatment of SH requires an implementation plan that includes the following actionable steps:Establish a commitment from hospital administration and medical leadership to reduce SH.Raise institutional awareness of the issue by comparing hospital and nursing units based on performance quality scorecards.Create a multidisciplinary team that includes physicians, pharmacists, nurses, diabetic educators, medication safety officers, case managers, and long-term healthcare professionals. This team will:Develop a system to identify patients receiving anti-diabetic medications (sulfonylureas, insulins, etc.) in the Electronic Health Record (EHR).Implement real-time surveillance methods, analysis tools, and point-of-care blood glucose (BG) monitoring and reporting systems.Create insulin order sets that could be modified to reduce risks of hypoglycemia.Coordinate glucose monitoring, automate insulin dose calculations, insulin administration, and meal delivery during changes of shift and times of patient transfer.Develop a systematic approach to reduce SH and implement universal best practices.Continuously monitor the incidence of SH in the hospital, and use the results of this monitoring in medical staff education sessions as a part of Continuous Quality Improvement (CQI).The Performance GapHypoglycemia is a common problem for many patients with diabetes, and it can also occur in non-diabetics in a hospital setting. . Mild episodes can cause unpleasant symptoms and disrupt daily activities. Severe hypoglycemia (SH) can result in disorientation and unusual behavior, and may be life-threatening. Frequent hypoglycemia is associated with increased morbidity, length of stay, and mortality. Hypoglycemia has been associated with mortality in the intensive care units \cite{Elliott_2012}. Moderate and SH are strongly associated with increased risk of death, especially from distributive shock \cite{2012}. This is by means of impairment of autonomic function, alteration of blood flow and composition, white cell activation, vasoconstriction, and the release of inflammatory mediators and cytokines \cite{Adler_2008},\cite{Wright_2008}. The prevalence of hypoglycemia (serum glucose <70 mg/dL) was reported as 5.7% of all point-of-care blood glucose (BG) tests in a 2009 survey of 575 hospitals.\cite{Swanson_2011}. The definition of SH (a low BG level that requires the assistance of another person for recovery), is a level <40 mg/dL, has been adopted as the level likely to cause harmin the hospital setting \cite{Schwartz_2007}. SH is a preventable harm. Early therapeutic management of mild hypoglycemia can prevent more SH episodes. In addition, literature showed that clinicians do not consistently adjust their patient’s anti-diabetic regimens appropriately following treatment of hypoglycemia, placing the patient at additional risk \cite{Boucai_2011},\cite{DiNardo_2006}.Causative factors that may lead to the development of hypoglycemia for inpatients may include excessive insulin dose, inappropriate timing of insulin or anti-diabetes therapy, unaddressed antecedent hypoglycemia or changes in the nutritional regimen, creatinine clearance changes, or steroid dose (9)\cite{Deal_2011}. Failure of effective BG monitoring and communication between physicians, pharmacists and nurses can also contribute to the problem. The diverse nature of potential errors in the treatment of inpatients with SH supports the need for a decision-making model that can be used to predict and prevent SH episodes and improve overall patient safety and outcomes.Closing the performance gap will require hospitals and healthcare systems to commit to action in the form of specific leadership, practice, and technology plans.Leadership PlanThe plan must include the fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action \cite{51}.Hospital governance and senior administrative leadership (medical, pharmacy, and nursing) must fully understand the performance gaps in their own healthcare system.Hospital governance, senior administrative leadership, and clinical/safety leadership must close their own performance gaps by implementing a comprehensive approach.Hospitals should set a goal date for the implementation of the corrective plan, with measurable quality indicators and milestones.Specific budget allocations for the plan should be evaluated by governance boards and senior administrative leaders.Clinical/safety leadership should endorse the plan and ensure implementation across all providers and systems.Practice PlanEach hospital should create a multidisciplinary team, which includes physicians, pharmacists, nurses, diabetic educators, medication safety officers, case managers, and long-term healthcare professionals).Develop a systematic approach to reducing severe hypoglycemia:Identify events and prioritizeRaise institutional awarenessCompare hospitals and nursing units based on performance quality scorecards (use harm rate for at-risk patient days: # of events/# of patient days during hospital stay when a diabetic agent is ordered at any time)Encourage nurses to enter hypoglycemia into safety event self-reporting siteCommunicate to the hospital leadership boardSend letters to physicians and providers (from case managers)Educate hospital staff, providers and patients – hospital newsletter and posters made for each hospital/nursing unit listing known and assumed solutions to hypoglycemia (e.g., “STOP Hypoglycemia!”)Kickoff reception for safety initiativeFrequent monitoring of glucose levels in patients who are at risk.Implement foundational Best Practices and “Just Do Its” (Appendices A and B)Establish a Hypoglycemia Task Force for the hospital ○Propose multidisciplinary diabetes safety team at each hospitalAdopt foundational best practices (literature-based recommendations for all hospitals)Implement “Just Do Its!” (or “Start Nows”) – these should be safe and reasonable interventions tested internallyAdopt ISMP recommendations for U-500 insulin precautions (Appendix C)Event investigation and collect causative factorsCausative Factors (to consider as part of analysis tool):Insulin stackingWrong drug, dose, route, patient, or time Insufficient glucose monitoringBasal heavy regimenDecreased nutritional intakeEvent related to outpatient or emergency department drug administrationEvent while treating elevated potassiumGlucose trend not recognizedHigh dose sliding scale insulin 10Home regimen continued as inpatientSignificant reduction in steroid doseSulfonylurea-related hypoglycemiaInsulin administration and food intake not synchronizedPOC glucose reading not linked to insulin administration POC glucose reading not synchronized with food intakeAnalysis tool forms reviewed by either pharmacist and/or nurse in a timely manner (e.g., 72 hours) for causative factors; communicate findings with physician(s)Results are collated and reported to Medication Safety Committee and the Pharmacy and Therapeutics CommitteeIdentify interventions (evidence-based and expert opinion) that are used to resolve the most common or most harmful causative factorsTrack the interventions and create customized action plans based on an integrated results dashboardShare best practices within hospital and to other hospitalsShare strategies and implement informed interventions on target floors and patients.Technology PlanSuggested practices and technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. As other options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org.Implement glycemic management clinical decision support for insulin therapy recommendation, based on individual responses to insulin and designed for mitigation of all types of hypoglycemia.This would include all of the following bullet points with significant additional safety features.Implement real-time surveillance method for informatics alerts: “High-Risk Sulfonylurea Alert” and “Hypoglycemia Risk Alert”.Implement an automated hypoglycemia event analysis tool (to discover local causes of hypoglycemia and guide future interventions).Implement point-of-care BG monitoring and reporting systems, including quality assurance reports to audit compliance with hypoglycemia management goals and restriction of insulin utilization.Implement automated triggers for most common causative factors of hypoglycemia, an electronic tracking system for SH events, interventions used and clinical outcomes.Implement a results dashboard for each nursing unit within the hospital and Best Practices used to resolve the hypoglycemic event(s).Set restrictions for the prescribing of U-500 Regular Insulin to only specialists and under special circumstances in CPOE.

Executive Summary ChecklistIn order to implement a program to eliminate central line-associated bloodstream infections (CLABSIs) the following implementation plan will require these actionable steps. The following checklist was developed by Dr. Peter Pronovost, in 2001. This checklist reduces infections when inserting a central venous catheter (CVC) \cite{00025}.Commitment from hospital leadership to support a program to reduce and then eliminate CLABSIs.Implement evidence-based guidelines to prevent the occurrence of CLABSIs, including: insertion, maintenance, and standardized access procedures.Such as: Arrow International® PSI with Integral Hemostasis Valve/Side Port or Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip®, ARROWg+ard Blue PLUS® Catheter and Sharps Safety FeaturesDoctors should:Perform a “time-out”Wash their hands with soap.Clean the patient’s skin with chlorhexidine antiseptic.Put sterile drapes over the entire patient.Wear a sterile mask, hat, gown and gloves.Put a sterile dressing over the catheter site.Develop an education plan for attendings, residents and nurses to cover key curriculum pertaining to the prevention, insertion and maintenance of central lines.Encourage continuous process improvement through the implementation of quality process measures and metrics.Standardize a central-line kit based on the needs of your facility, and implement technology that will have a significant return on investment (ROI) such as:Arrow International® PSI Kit with Integral Hemostasis Valve/Side Port or Arrow International® Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip®, ARROWg+ard Blue PLUS® Catheter and Sharps Safety Features.Efforts should be focused on eliminating all blood draws from central access catheters. This includes patient with longer-standing catheters (e.g. dialyses catheters).All CLABSIs should have a root cause analysis (RCA) completed by the unit where the infection occurred with multidisciplinary participation including nursing, physicians and infection prevention specialists. All learnings from the RCA should be implemented.The Performance GapEach year in the United States there are more than 700,000 healthcare-associated infections (HAIs) resulting in 75,000 deaths and $28-$45 billion in extra health care costs \cite{Klevens_2007},\cite{00026}.Central line-associated bloodstream infections (CLABSIs) are amongst the most commonly occurring HAIs and have a mortality rate of 12-25% (3). An estimated 41,000 patients in US hospitals acquire central line-associated infections each year \cite{21460264}. Heavy bacterial colonization at the insertion site, catheter placement in the arm or leg rather than the chest, catheterization longer than 3 days, and insertion with less stringent barrier precautions all significantly increase the risk of catheter-related infection \cite{Mermel_1991}. While intensive care unit (ICU) patients are at the highest risk for CLABSIs, central venous catheters are becoming increasingly utilized outside the ICU, exposing more patients to the risk. In fact, recent data suggest that the greatest numbers of patients with central lines are in hospital units outside the ICU \cite{Vonberg_2006}. While central line use is increasing outside the ICU, since 2008 CMS has implemented a policy of reduced reimbursement for reasonably preventable hospital-acquired conditions, including CLABSI. This policy change can represent a significant financial burden to the hospital because increased hospital costs due to CLABSI can be as much as $23,000 per case \cite{00026}.CLABSI and other HAIs, however, are largely preventable. Interventions focusing on reducing CLABSIs in particular resulted in reductions ranging from 38 to 71%.3 Pronovost et al. for example, observed a 66% decrease in CLABSIs after implementing a multi-component intervention in the ICUs of 67 Michigan hospitals \cite{Pronovost_2006}. In a separate study conducted in 32 hospitals in Pennsylvania, CLABSIs decreased by 68%, following targeted interventions between April 2001 and March 2005 \cite{00027}. Other studies have shown similar reductions in CLABSI, saving lives and dramatically reducing costs \cite{Rosenthal_2012},\cite{Hong_2013},\cite{Gozu_2011}.A variety of guidelines and recommendations have been identified to prevent CLABSIs including those published by The Healthcare Infection Control Practices Advisory Committee, \cite{21511081}. The Institute for Healthcare Improvement (IHI)\cite{00028} and the Agency for Healthcare Research and Quality (AHRQ) \cite{00029}.Important shared components of these recommendations include: implementing a method to detect the true incidence of CLABSI, including information technology to collect and calculate catheter days; providing adequate infrastructure for the intervention including an adequately staffed infection prevention and control program and adequate laboratory support for timely processing of samples; implementing a catheter insertion checklist; monitoring the continued need for intravascular access on a daily basis; and measuring unit- specific incidence of CLABSI as part of performance evaluations.It is estimated that the use of process change and technology to reduce CLABSI can save up to $2.7 billion per year while significantly improving quality and safety \cite{00026}. Closing the performance gap will require hospitals and healthcare systems to commit to action in the form of specific leadership, practice, and technology plans, examples of which are delineated below for utilization or reference. This is provided to assist hospitals in prioritizing their efforts at designing and implementing evidence-based bundles for CLABSI reduction.Leadership PlanHospital governance and senior administrative leadership must commit to becoming aware of major performance gaps in their own organization.Hospital governance, senior administrative leadership, and clinical/safety leadership must close their own performance gap by implementing a comprehensive approach.Healthcare leadership must reinforce their commitment by taking an active role in championing process improvement, giving their time, attention and focus, removing barriers, and providing necessary resources.Leadership must demonstrate their commitment and support by shaping a vision of the future, clearly defining goals, supporting staff as they work through improvement initiatives, measuring results, and communicating progress towards goals. Actions speak louder than words. As role models, leadership must ‘walk the walk’ as well as ‘talk the talk’ when it comes to supporting process improvement across an organization.There are many types of leaders within a healthcare organization and in order for process improvement to truly be successful, leadership commitment and action are required at all levels. The Board, the C-Suite, senior leadership, physicians, directors, managers, and unit leaders all have important roles and need to be engaged.Change management is a critical element that must be included to sustain any improvements. Recognizing the needs and ideas of the people who are part of the process—and who are charged with implementing and sustaining a new solution—is critical in building the acceptance and accountability for change. A technical solution without acceptance of the proposed changes will not succeed. Building a strategy for acceptance and accountability of a change initiative greatly increase the opportunity for success and sustainability of improvements. “Facilitating Change,” the change management model The Joint Commission developed, contains four key elements to consider when working through a change initiative to address HAIs (Appendix A).In addition to the change management model leaders should:Include fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action.Meet with ICU team, infection control staff, quality and safety leaders, nurse educators, and physician champions.Understand barriers (walk the process)Use 4E grid to develop strategy to engage, educate, execute and evaluateEngage: stories, show baseline dataEducate staff on evidenceExecute practice changeEvaluate feedback performance, view infections as defectsUse surveillance data to drive improvementMonitor and provide feedback of compliance with best practice over timePractice PlanUse of current evidence-based guidelines and/or implementation aids regarding the prevention of CLABSIs:InsertionCreate a standardized central line insertion kit or line cart that contains all needed supplies (see Technology Plan).Ensure insertion checklist is in your electronic medical record.Wear sterile clothing – gowns, mask, gloves and hair covering.Cover patient with a sterile drape, except for a very small hole where line goes in.Maintain strict sterile technique when placing the line.Hand Hygiene - Perform hand hygiene procedures, either by washing hands with conventional soap and water or with alcohol-based hand rubs (ABHR). Hand hygiene should be performed before and after palpating catheter insertion sites as well as before and after inserting, replacing, accessing, repairing, or dressing an intravascular catheter \cite{Boyce_2002}. Palpation of the insertion site should not be performed after the application of antiseptic, unless aseptic technique is maintained \cite{12517020}.Ultrasound guidance should be used for all non-emergent central line placements.For directly inserted central lines, avoid veins in arm and leg, which are more likely to get infected than veins in chest.Before commencing the procedure, perform a “time-out.”Position patient appropriatelyPrepare insertion sitePrepare clean skin with a 0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter insertion and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives.No iodine ointment - Do not use topical antibiotic ointment or creams on insertion sites, except for dialysis catheters, because of their potential to promote fungal infections and antimicrobial resistance.When inserting near the lungs, ensure line aspirates blood to ensure proper catheter placement.Apply a sterile dressing to the site.Prepackaged or filled insertion cart, tray or box – cart/tray/box that contains all the necessary supplies.Insertion checklist with staff empowerment to stop non-emergent procedure - include a checklist to ensure adherence to proper practices;Full sterile barrier for providers and patients - use maximal sterile barrier precautions, including the use of a cap, mask, sterile gown, sterile gloves, and a sterile full body drape, for the insertion of CVCs, PICCs, or guidewire exchange. Use a sterile sleeve to protect pulmonary artery catheters during insertion.Insertion training for all providers.MaintenancePerform daily assessments of need for line and remove when no longer needed.Daily discussion of line necessity, functionality and utilization including bedside and medical care team members.Discuss with the medical team continued necessity of line.Discuss with the medical team the function of the line and any problems.Discuss with the medical team the frequency of access and utilization of line. Consider bundling labs and line entries.Consider best practice is documentation that the discussion occurred in the medical record.Regular assessment of dressing to assure clean/dry/occlusive:Replace catheter site dressing if the dressing becomes damp, loosened, or visibly soiled.Replace dressings used on short-term central venous catheters sites according to CDC or institution’s protocol.Daily CHG bathing and linen changes - Follow manufacturer recommendations for usagePerform weekly rounds.Send monthly data to team and leadership.Celebrate successPerform in-depth case reviews in instances where infections do occur (identify the risk(s) that could’ve been avoided and modifications needed moving forward, if any).Utilize a systematic approach to review all hospital acquired CLABSIsStandardized Access Procedure 17Refer to Hand Hygiene details in APSS #2A.Disinfect cap before all line entries by scrubbing with an appropriate antiseptic and accessing the port only with sterile devices.Scrub the Hub: Alcohol (15 second scrub + 15 second dry) or CHG (30 second scrub + 30 second dry).Standardized dressing, cap and tubing change procedures/timing:Scrub skin around site with CHG for 30 seconds (2 minute for femoral site), followed by complete drying. (Note: there may be institutional preference for CHG use for infant < 2 months of age).Change crystalloid tubing no more frequently than every 72 hours.Change tubing used to administer blood products every 24 hours or more frequently per institutional standard.Change tubing used for lipid and TPN infusions every 24 hours.Document date dressing/cap/tubing was changed or is due for change.Consider when hub of catheter or insertion site are exposed, wear a mask (all providers and assistants) shield patient’s face, ETT or trach with mask or drape.In the Neonatal ICU:\cite{Miller_2010},\cite{Wheeler_2011},\cite{Milstone_2013},\cite{00030}A monthly report-out at team/quality committee and leadership meetings.Implement standardized central venous catheter (CVC) practices:Insertion checklistDaily assessmentElectronic health record prompt to remove catheter based on feeding volume24-hour catheter tubing change, experienced nurses onlyEnhanced nursing education and competency for CVC careEducationNursing education – care and maintenance bundleNeonatal ICU nursing education – enhanced and competency for CVC careCentral Line Simulation ProgramDevelop education for attendings, residents, nursesKey Curriculum Concepts – reinforcementHand hygieneAppropriate gowning and glovingKey Curriculum Concepts – newStandardized central line insertion best practiceUltrasound guided cannulationUpdated insertion checklistMaintaining sterile technique – immediate feedbackCentral Line Navigator documentationGeneral Medical EducationMD rounding navigators (removal prompt)Resident infection prevention trainingEvidence-based practice adherenceRemain current with new literature findings, e.g., “Guidelines for the Prevention of Intravascular Catheter-Related Infections” 2011 compendium by the CDC \cite{Miller_2010}.Patient education document (Figure 1).

Executive Summary Checklist

In order to implement a program to eliminate Clostridium difficile infection (CDI) the following implementation plan will require the actionable steps. The following checklist was adapted from the core prevention strategies recommended by the CDC \cite{00015}.

Clean and disinfect equipment and environment Equipment such as blood pressure cuffs and pulse oximeters are frequently not cleaned between patients. Might be useful to include some examples of equipment to ensure routine cleaning.

Use a laboratory-based alert system for immediate notification of positive test results

Implement technologies that support proper surface cleaning and utilize as part of a defined environmental control best practice program

Encourage continuous process improvement through the implementation of quality process measures and metrics.

All CDIs should have a root cause analysis (RCA) completed by the unit where the infection occurred with multidisciplinary participation including nursing, physicians and infection prevention specialists. All learnings from the RCA should be implemented.

The Performance Gap

Clostridium difficile (C. diff) is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B \cite{00016}. It is a common cause of antibiotic-associated diarrhea (AAD), and it accounts for 15-25% of all episodes of AAD. Various diseases result from C. diff infection (CDI), including: pseudomembranous colitis (PMC), toxic megacolon, perforations of the colon, sepsis, and death (rarely). The clinical symptoms include watery diarrhea, fever, loss of appetite, nausea and abdominal pain/tenderness. Certain patient populations are at an increased risk for C. diff, including patients with: antibiotic exposure, proton pump inhibitors, gastrointestinal surgery/manipulation, long length stay in healthcare settings, a serious underlying illness, immunocompromising conditions and advanced age.

Clostridium difficile is shed in feces. Any surface, device, or material that becomes contaminated with feces may serve as a reservoir for the C. diff spores. The spores are primarily transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item. It is important to note that C. diff spores are not killed by alcohol-based hand rubs \cite{Oughton_2009},\cite{Jabbar_2010},\cite{18177221}. The WHO recommends washing hands with soap and water before gloving and after degloving \cite{00017}. CDI will resolve within 2-3 days of discontinuing the antibiotic to which the patient was previously exposed in approximately 20% of patients. The infection can usually be treated with an appropriate course (about 10 days) of antibiotics. After treatment, repeat C. diff testing is not recommended if the patients’ symptoms have resolved, as patients may remain colonized. The differences between C. diff colonization and infection are important to note:

Common laboratory tests used to diagnose C. diff infection include stool culture, molecular tests, antigen detection for C diff, toxin testing (tissue culture cytoxicity assay or enzyme immunoassay). The toxin is very unstable and degrades at room temperature, and may be undetectable within 2 hours after collection of a stool specimen. False-negative results occur when specimens are not promptly tested or kept refrigerated until testing can be done.

Leadership Plan

Healthcare leadership should support the design and implementation of an antimicrobial stewardship program

Senior leadership will need to integrate surveillance and metrics to ensure prevention measures are being followed

Leadership commitment and action are required at all levels for successful process improvement

Practice Plan

Establish and consistently implement Clostridium difficile infection (CDI) prevention guidelines that focus on the education of healthcare providers, patients, and families, surveillance, hand hygiene, contact and isolation precautions, and establishment of an antimicrobial stewardship program \cite{00016},\cite{00017}. An example of an evidence-based approach is the Association for Professionals in Infection Control and Epidemiology Guide to Preventing Clostridium difficile Infections. This Guide can be accessed online \cite{00018}.

We have also listed key elements of CDI prevention below:

Surveillance

Implement a facility-wide CDI surveillance method of both process measures and the infection rates to which the processes are linked.

Hand Hygiene \cite{Oughton_2009}-\cite{00017}

It is recommended that healthcare providers wash hands with soap and water before donning gloves and following glove removal when caring for patients with CDI. No agent, including alcohol-based hand rubs, is effective against C. diff spores.

Appropriate use and removal of gloves is essential when caring for patients with diarrheal illnesses, like CDI.

Contact/Isolation Precautions

Use Standard Precautions for all patients, regardless of diagnosis.

Place patients with CDI on Contact Precautions in private rooms when available.

Perform hand hygiene and put on gown and gloves before entry to the patient’s room.

Communication devices such as walkie-talkies used by nurses to communicate with the nursing station as well as personal cell phones carried by healthcare personnel.

Antimicrobial Stewardship and CDI

Implement a program that supports the judicious use of antimicrobial agents \cite{00020}.

The program should incorporate a process that monitors and evaluates antimicrobial use and provides feedback to medical staff and facility leadership.

Technology Plan

Suggested practices and technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. As other options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org

Implement technologies that support proper surface cleaning and utilize as part of a defined environmental control best practice program

Implement technologies that support proper hand hygiene and utilize as part of a defined hand hygiene best practice program such as product utilization and staff movement tracking, sensor bracelets, alcohol sensing technologies.

See APSS 2A for a list of hand hygiene technology suppliers

Metrics

Topic:

Healthcare-associated Clostridium Difficile Infection Rate (CDiff)

Rate of patients with a healthcare associated CDI per 1,000 patient days

Outcome Measure Formula:

Numerator: Number of healthcare associated CDI based on CDC NHSN definitions \cite{00020}

Denominator: Total number of patient days based on CDC NHSN definitions

*Rate is typically displayed as Infections/1000 Patient Days

Metric Recommendations:

Executive Summary Checklist

In order to establish a program to eliminate Catheter-associated Urinary Tract Infections (CAUTI) an implementation plan with the following actionable steps must be completed. This checklist was adapted from the core prevention strategies recommended by the CDC \cite{gould2010catheter}.

Hospital governance and senior administrative leadership must champion efforts to raise awareness of the high incidence of CAUTIs and prevention measures.

Healthcare leadership must support the design and implementation of standards and training programs on catheter insertion and manipulation.

Insert catheters only for appropriate indications

Ensure that only properly trained persons insert and maintain catheters

Insert catheters using aseptic technique and sterile equipment

Maintain unobstructed urine flow

Perform perineal care routinely for patients who have indwelling catheters to reduce the risk of skin breakdown and irritation

The Performance Gap

Urinary tract infections are the most common nosocomial infection, accounting for up to 40% of infections reported in acute care hospitals \cite{20004811}. There are an estimated 560,000 nosocomial UTIs annually in the United States with an estimated cost of $450 million annually \cite{Klevens_2007}. Up to 80% of UTIs are associated with the presence of an indwelling urinary catheter \cite{Apisarnthanarak_2007}.

A catheter-associated urinary tract infection (CAUTI) increases hospital cost and is associated with increased morbidity and mortality \cite{15774051,18165672,19292664}. There are an estimated 13,000 deaths annually attributable to CAUTIs \cite{17357358}. CAUTIs are considered by the Centers for Medicare and Medicaid Services to represent a reasonably preventable complication of hospitalization. As such, no additional payment is provided to hospitals for CAUTI treatment-related costs.

Urinary catheters are used in 15-25% of hospitalized patients \cite{10466554} and are often placed for inappropriate indications. According to a 2008 survey of U.S. hospitals >50% did not monitor which patients were catheterized, and 75% did not monitor duration and/or discontinuation \cite{18171256}. The pathogenesis of CAUTIs may occur early at insertion or late by capillary action, or occur due to a break in the closed drainage tubing or contamination of collection bag urine \cite{11294737}. The source of the organisms may be endogenous (meatal, rectal, or vaginal colonization) or exogenous, usually via contaminated hands of healthcare personnel during catheter insertion or manipulation of the collecting system.

Prevention strategies have been recommended by HICPAC/Centers for Disease Control and Prevention \cite{20156062}. The Core Strategies are supported by high levels of scientific evidence and demonstrated feasibility, whereas the Supplemental strategies are supported by less robust evidence and have variable levels of feasibility.

Core Prevention Measures include:

Insert catheters only for appropriate indications

Compliance with evidence-based guidelines e.g. Surgical Care Improvement Project (SCIP-Inf-9) requires urinary catheter removal on Postoperative Day 1 (POD1) or Postoperative Day 2 (POD 2) with day of surgery being day zero

Leave catheters in-place only as long as needed

Only properly trained persons insert and maintain catheters

Insert catheters using aseptic technique and sterile equipment

Maintain a closed drainage system

Maintain unobstructed urine flow

Hand hygiene and standard (or appropriate) isolation precautions

Supplemental Prevention Measures Include:

Alternatives to indwelling urinary catheterizations

Portable ultrasound devices to reduce unnecessary catheterizations

The following practices are NOT recommended for CAUTI prevention (HICPAC guidelines):

Complex urinary drainage systems

Changing catheters or drainage bags at routine, fixed intervals

Routine antimicrobial prophylaxis

Cleaning of periurethral area with antiseptics while catheter is in place

Irrigation of bladder with antimicrobials

Instillation of antiseptic or antimicrobial solutions into drainage bags

Routine screening for asymptomatic bacteriuria (ASB)

Prior to the implementation of new preventive measures, an evaluation should assess baseline policies and procedures with regard to CAUTI. New policies and practices should be tracked once implemented to ensure adherence and to remove any barriers to effective change.

Leadership Plan

Hospital governance and senior administrative leadership must champion efforts in raising awareness around the high incidence of CAUTIs and prevention measures.

Healthcare leadership should support the design and implementation of standards and training programs on catheter insertion and manipulation

Senior leadership will need to address barriers, provide resources (budget/personnel), and assign accountability throughout the organization

Leadership commitment and action are required at all levels for successful process improvement

Practice Plan

Reduce the use and duration of use of urinary catheters

While there have been multiple attempts to deploy antimicrobial catheters to reduce the rate of infection, there is no literature to support that this technology has made a significant impact.

It has been estimated that 80% of hospital-acquired UTIs are directly attributable to use of an indwelling urethral catheter \cite{15175612} and studies have shown that there is a very high utilization in patients where it was not indicated or for durations that may have been longer than clinically necessary \cite{saint2000physicians}.

Thus the greatest opportunities to reduce the rate of UTI are 1) to place catheters only for appropriate indications and 2) to limit the duration of catheter placement.

Technology Plan

Suggested practices and technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. As other options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org.

Implement an anti-infective Foley catheter kit with enhanced components to prepare, insert and maintain a safe urinary catheter. One standard kit that has been effective:

BARDEX® I.C. Advance Complete Care® Trays

Metrics

Topic:

Catheter-associated urinary tract infections (CAUTI)

Rate of patients with CAUTI per 1,000 urinary catheter-days - all in-patient units